Atrasentan Spermatogenesis and Testicular Function
- Registration Number
- NCT02118714
- Lead Sponsor
- AbbVie
- Brief Summary
This study is being conducted to evaluate the effects of Atrasentan on sperm production and testicular function in male subjects with Type 1 or 2 Diabetes and Nephropathy.
This study included 2 periods: a Treatment Period (up to 26 weeks) followed by an Observational Period (up to an additional 52 weeks).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
- Males 30 to 75 years of age
- Type 1 or 2 diabetes and receiving treatment with at least one anti-hyperglycemic medication and angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARB) (renin-angiotensin system [RAS] inhibitor)
- Estimated Glomerular Filtration Rate (eGFR) equal to or greater than 35 mL/min/1.73 m^2 with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula and Urine Albumin-to-Creatinine Ratio (UACR) equal to or greater than 30 and less than 5,000 mg/g creatinine.
- Able to provide a semen specimen at the required intervals.
- Baseline sperm concentration equal to or greater than 30 million per mL.
- Treatment with hormone suppressive agents or cancer chemotherapy within the 6 months prior to the initial screening visit or planned during the study.
- History of severe peripheral edema or facial edema unrelated to trauma or history of myxedema in the prior 4 weeks prior to screening.
- History of pulmonary hypertension, pulmonary fibrosis or any lung disease requiring oxygen therapy.
- Documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure.
- Currently receiving or has received hormone replacement therapy within 6 months prior to screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Atrasentan Atrasentan Atrasentan 0.75 mg administered orally once daily (QD) for 26 weeks
- Primary Outcome Measures
Name Time Method Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26 Up to 26 weeks Percentage of Subjects with a Sperm Concentration \< 15 million per mL by Treatment Week 26. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Entered the Observation Period and Did Not Return to Within 15% of Baseline Sperm Concentration or Above During the 52-Week Observational Period Up to 52 weeks after the Treatment Period The percentage of participants who entered the Observational Period and did not return to within 15% of Baseline sperm concentration or above during the 52-week Observational Period. Duplicate semen samples were to be collected during the Observational Period. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 Duplicate semen samples will be collected during the Treatment and Observational Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in sperm concentration.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52 Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a lower sperm motility (worsening).
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 Duplicate semen samples will be collected during the Treatment and Observational Periods. The percentage of sperm with normal versus abnormal morphology will be determined via microscopic analysis. A positive change from baseline indicates an improved sperm morphology.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52 Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in semen volume.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum testosterone.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 Serum hormones levels were tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum estradiol.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH) From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52 Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum lutenizing hormone.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH) From Week 0 to Treatment Week 26 and Observation Week 52 Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum follicle stimulating hormone.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum Inhibin B.
Trial Locations
- Locations (13)
Tulane Univ /ID# 130308
🇺🇸New Orleans, Louisiana, United States
Frank Clark Urology Center /ID# 147794
🇺🇸Santa Monica, California, United States
Southern IL Univ School of Med /ID# 129010
🇺🇸Springfield, Illinois, United States
Alliance Research Centers /ID# 125945
🇺🇸Laguna Hills, California, United States
Research by Design, LLC /ID# 160784
🇺🇸Evergreen Park, Illinois, United States
Crescent City Clinical Res Ctr /ID# 150989
🇺🇸Metairie, Louisiana, United States
Ospedale S. Carlo Borromeo /ID# 151672
🇮🇹Milan, Italy
SCDU Nefrologia e dialisi-CMID /ID# 151673
🇮🇹Torino, Italy
Hospital Universitario Reina S /ID# 151692
🇪🇸Cordoba, Spain
Albany Medical College /ID# 131068
🇺🇸Albany, New York, United States
Urologic Consultants of Southeastern Pennsylvania /ID# 124277
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Eastern Virginia Med School /ID# 153740
🇺🇸Norfolk, Virginia, United States
Charite Research Organisation GmbH /ID# 154264
🇩🇪Berlin, Germany